NEW YORK, March 1, 2023BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been enrolled in BeyondSpring’s Phase 2 investigator-initiated trial with lead asset, Plinabulin, in combination with Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab) and Docetaxel for previously treated patients with metastatic non-small cell lung cancer (NSCLC) and progressive disease after immunotherapy (anti-PD-1 / PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy.

Most patients experience disease progression after immune checkpoint inhibitor-based (ICI) treatment regimens. BeyondSpring’s triple-combination therapy has the potential to improve ICI resistance and provide a new treatment option for metastatic NSCLC patients previously treated with an immunotherapy. The study1 is actively recruiting at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine, as principal investigator. Patients will receive the following doses during each three-week cycle (via IV infusions)2:

  • Plinabulin at 30 mg / m2 on Days 1 and 8
  • Keytruda at 200 mg on Day 1
  • Docetaxel at 75 mg / m² on Day 1

“While PD-1 / PD-L1 inhibitors have significantly advanced cancer treatment, patients still experience disease progression even after receiving these therapies,” said Dr. Wang. “This triple combination study is bringing us one step closer to helping with this unmet medical need. Plinabulin’s unique, immune-enhancing mechanism of action has a proven anti-cancer benefit that we believe will synergize with Docetaxel and Keytruda and re-sensitize patients who progressed after immunotherapy. In fact, Plinabulin has shown a 40 percent response rate in its immune-oncology combination in small-cell lung cancer patients who experienced disease progression after immunotherapy3. I look forward to evaluating this treatment further in the clinic to ensure that cancer patients all over the world have access to the most advanced, cutting-edge therapies.”

“As 25 to 30 percent of patients suffering from metastatic NSCLC have a life expectancy of under three months4, it is our mission to find better treatments that extend these patients’ lives so that they can see a child being born or a graduation from high school – every moment matters. Enrolling the first patient in this trial is a pivotal moment as we look to bring more promising therapies to patients in need. This new combination approach has the potential to make meaningful differences in patient quality of life and survival,” added Dr. Lan Huang, Co-Founder, Chairman and CEO at BeyondSpring.

  1. Liu J, et al. Study protocol of KeyPemls-004: A phase 2 study of pembrolizumab in combination with plinabulin and docetaxel in previously treated patients with metastatic non-small cell lung cancer and progressive disease (PD) after immunotherapy (PD-1/PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy. Thoracic Cancer, 2023 Feb 1.doi: 10.1111/1759-7714.14806. Online ahead of print.
  2. A Phase 2 Study of Pembrolizumab in Combination With Plinabulin and Docetaxel in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer and Progressive Disease (PD) After Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) Alone or in Combination With Platinum-doublet Chemotherapy (KeyPemls-004). gov identifier: NCT05599789. Conducted by Peking Union Medical College Hospital, BeyondSpring Pharmaceuticals Inc., and Merck Sharp & Dohme LLC.
  3. Guo H, et al. “How Long Have I Got?” in Stage IV NSCLC Patients With at Least 3 Months Up to 10 Years Survival, Accuracy of Long-, Intermediate-, and Short-Term Survival Prediction Is Not Good Enough to Answer This Question. Frontiers in Oncology 2021 Dec 21; 11:761042. doi: 10.3389/fonc. 2021.761042. eCollection
  4. Malhotra J, et al. A phase I trial of plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer (SCLC): Big Ten Cancer Research Consortium (BTCRC-LUN17-127) study. JCO, 39(15), suppl.8570 (2021 ASCO Meeting).

About BeyondSpring

BeyondSpring is a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead asset, Plinabulin, is being developed as a potential “pipeline in a drug” in various cancer indications as a direct anti-cancer agent and to prevent chemotherapy-induced neutropenia (CIN). The Plinabulin-G-CSF combination for CIN prevention has demonstrated positive Phase 3 data in the PROTECTIVE-2 study. In the DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, the Plinabulin-Docetaxel combination met the primary endpoint of extending overall survival compared to Docetaxel alone in second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild type). Additionally, Plinabulin is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1 / PD-L1 antibodies in seven different cancers. Lastly, BeyondSpring’s pipeline includes three preclinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform with initial R&D collaboration with Eli Lilly.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

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